Meningitis scandal shows regulators failed to keep up

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The fallout from the meningitis scandal seems to worsen every day. Tainted vials of steroids from New England Compounding Center, a Framingham specialty pharmacy, have led to more than 300 illnesses, at least 28 deaths, and now, a voluntary recall of products from the company’s sister pharmacy, which could have ripple effects in hospitals nationwide. State officials, once cautious, have now stepped up their rhetoric, but their newfound fury calls into relief a larger problem: How state regulators somehow failed to notice, over the past decade, the dramatic growth and apparent production shortcuts that occurred in a compounding pharmacy industry
that has come to play a critical role in medical treatment.

Compounding pharmacies operate under a legal structure that treated them as mom-and-pop operations, which create small quantities of carefully prepared medicine for patients with particular needs. But New England Compounding Center and its sister company, Westborough-based Ameridose, had much larger ambitions than the typical neighborhood drugstore. Apparently capitalizing on a culture of lax oversight, they wound up doing what amounts to mass production, potentially in violation of a state law that forbade them to dispense drugs without individual prescriptions.

Major pharmaceutical companies are subject to strict federal oversight. But the task of regulating compounding pharmacies fell to a once-obscure entity called the Massachusetts Board of Registration in Pharmacy. The 11 members of this board are appointed by the governor and work under the purview of the Department of Public Health’s Bureau of Health Care Safety and Quality. Board members are responsible for licensing pharmacists, ensuring high standards of professional conduct, and protecting the public welfare. By law, the bulk of the members are themselves pharmacists, presumably because people who know an industry intimately may be well equipped to police it. (Boards that oversee individual doctors and nurses operate in a similar way.)

Yet compared with its counterparts
in other states, the Massachusetts pharmacy board has suffered from a lack of transparency and efficiency. It does not produce an annual report, and until the current crisis struck, did not conduct regular unnanounced investigations of specialty pharmacies.

And in the specific case of New England Compounding Center, the board appears, in hindsight, to have exhibited a shocking lack of concern. Beginning in 1999, several complaints were lodged accusing the company of ignoring state regulations. But rather than reprimand the company and place it on probation, in 2004, the board apparently acceded to the demands of the company’s lawyers, and issued what amounted to a gentle slap on the wrist.

Making matters worse, at least in terms of appearance, is the fact that one of the board members, Sophia Pasedis — who was first appointed by Governor Mitt Romney in 2004, and reappointed by Governor Patrick in 2008 — works for Ameridose. When, in the aftermath of the scandal, state officials asked her to resign over questions about whether she properly recused herself from matters regarding New England Compounding and Ameridose, she refused.

The state has now issued emergency regulations that tighten oversight of compounding pharmacies, and Patrick has appointed a commission to further review the regulatory structure around this changing business. One question that should arise is whether a board comprised of pharmacists’ peers is the best way to regulate a rapidly growing compounding industry. Federal officials, led by US Representative Edward Markey, have pointed out that compounding pharmacies have resisted federal oversight, and have found ways to exploit the patchwork of state regulations.

Not every compounding pharmacy, it must be noted, operates this way; officials believe New England Compounding sought to expand its market share far more aggressively than similar businesses. But the board’s lax oversight has cast a shadow on the entire industry — as well as on the state Department of Public Health, and on the reputation of Massachusetts’ medical sector. That’s why it’s critical that Patrick’s new commission look beyond Band-aid patches and consider substantive, sweeping reforms — for the sake of the state’s quite important reputation for medical quality, and for the overall health of the public.